A Safety and Efficacy Study of DRM02 in Subjects With Plaque Psoriasis

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether DRM02 is safe and effective in the treatment of plaque psoriasis when applied twice daily for 6 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dermira, Inc.

Criteria

Inclusion Criteria:

• Male or female 18 to 70 years of age.

• Plaque-type psoriasis with two lesions of similar size and have an identical score of at least 6 but no more than 8 on the sum of the individual components of the Severity of Psoriasis Area Severity Index (PASI) at the Target Lesion scale.

• Male or non-pregnant, non-lactating females.

• Signed informed consent.

Exclusion Criteria:

• Subjects who have extensive, and/or 'inverse', and/or exfoliative psoriasis.

• Subjects who have taken any systemic treatment for psoriasis within the 4 weeks prior to baseline.

• Prior or concomitant use of topical treatments for psoriasis to within 10 cm of the target lesion within the 4 weeks prior to baseline.

• Use of Enbrel within the 4 weeks prior to baseline.

• Psoralen & ultraviolet A therapy (PUVA) or the use of ultraviolet B (UVB) therapy and/or excessive or prolonged exposure to ultraviolet light within the 4 weeks prior to baseline.

• Use of Humira or Remicade within the 3 months prior to baseline.

• Use of Stelara within the 6 months prior to baseline.

• Subjects who have taken oral retinoids for psoriasis within the 6 months prior to baseline.

• Subjects who have poor skin condition within 5 cm of the target lesion.

• Subjects who are current drug or alcohol abusers; have a history of immunodeficiency disease or are a poor medical risk because of other systemic diseases or active uncontrolled infections.

• Subjects with an unstable medical condition or a medical condition not adequately controlled with standard medical therapy.

• Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days

• Subjects who have a clinically significant laboratory value at screening.